| Autor: |
Michaud S; BioCanRx, Ottawa, ON K1H 8L6, Canada., Needham J; Canadian Cancer Trials Group, Kingston, ON K7L 3N6, Canada., Sundquist S; Canadian Cancer Clinical Trials Network (3CTN), Toronto, ON M5G 0A3, Canada., Johnson D; McPeak-Sirois Group for Clinical Research in Breast Cancer, Montreal, QC H2Y 2H2, Canada., Hanna S; The Cancer Collaborative, Montreal, QC H7W 0C3, Canada., Hosseinzadeh S; Novartis Pharma Canada, Dorval, QC H9S 1A9, Canada., Bartekian V; Vantage BioTrials, Montreal, QC H4M 2N9, Canada., Steele P; Colorectal Cancer Canada, Montreal, QC H3G 1J1, Canada., Benchimol S; Colorectal Cancer Canada, Montreal, QC H3G 1J1, Canada., Ross N; Nathalie Ross, Laval, QC H7L 4Z3, Canada., Stein BD; Colorectal Cancer Canada, Montreal, QC H3G 1J1, Canada. |
| Abstrakt: |
Background-to guide the implementation of patient centricity and engagement in cancer clinical trials (CTs) and to operationalize the Canadianized version of the Clinical Trials Transformation Initiative (C-CTTI) model, the development of a charter was identified by cancer CT stakeholders. Methods-the Canadian Cancer Trial Stakeholder Charter (the Charter) was initiated by Colorectal Cancer Canada (CCC) and developed via the-1-formation of an inclusive working group (WG) that drafted the document using recommendations collected during the development of the C-CTTI model; 2-socialization of the draft Charter to solicit feedback from cancer CT stakeholders, including those who attended the 2019 CCC Conference; and 3-incorporation of stakeholders' feedback and finalization of the Charter by the WG. Results-the Charter was built around five guiding principles-1-patient centricity; 2-commitment to education and training; 3-collaboration as equal and independent partners in research; 4-transparency and accountability; and 5-high standards in data collection integrity and honesty. These principles led to the Charter's five tenets, which stipulate stakeholder commitments, aiming to make CTs accessible to all patients, improve the design and implementation of CTs to benefit patients, expand recruitment and retention of patients in CTs, and further advance cancer research and treatment. Conclusions-the Charter is intended to integrate the patient voice into the Canadian cancer CT continuum. The next phases of the C-CTTI model include the adoption and implementation of the Charter, the establishment of a patient group training program, and the development of real-world evidence/real-world data methodologies. |
